BioSante: LibiGel Lives On, FDA Word On Bio-T-Gel May Come At Any Time

By Kinetic Investments:By Bert Wilkison
BioSante Pharmaceuticals, Inc. (BPAX) describes itself as a specialty pharmaceutical company focused on developing products for female sexual health and oncology. Its lead product candidate, Bio-T-Gel, a testosterone gel for male hypogonadism, is licensed to Teva Pharmaceutical (TEVA) and, somewhat befittingly, has PDUFA date scheduled for Valentine's Day (02/14/12).5-Day Chart
The company made headlines again when it released news this morning that the independent Data Monitoring Committee [DMC] has completed another unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study. The DMC recommended that the LibiGel safety study should continue, and perhaps just as important, without modifications. LibiGel is often referred to as Viagra for women. The company disclosed that, with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular [CV] events, with a lowerComplete Story »

By Williams Equity Analysis:
BioSante Pharmaceuticals (BPAX) is a biotech company based out of Illinois. The stock has risen about 40% since June 20th with the absence of any major news, so there is significant risk of a short-term pullback.
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ByAli Yasar:The news of failed Phase III efficacy studies on Libigel (testosterone gel) being used as a treatment for female sexual dysfunction (FSD) was a surprise to many Biosante Pharmaceuticals (BPAX) investors.

By James Stocklasar Thomas Jr.:Biosante (BPAX) deserves attention from the Seeking Alpha community, especially since it was at center stage of the penny-land biotech community going into December 2011. The question on Biosante's investors' minds is: Will Libigel make a comeback? I imagine answers range from the pejorative to unbridled optimism, from, 'No way!' to 'Yes way!'

By M.E. Garza:
BioSante Pharmaceuticals, Inc. (BPAX) has just shared some additional data from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Will that be enough to break shares away from down-trending resistance levels?

M.E. Garza submits:
Shares of BioSante Pharmaceuticals (BPAX) were up slightly in early trading after the company said Wednesday that the Food and Drug Administration will review an application for a testosterone gel it developed and then licensed to a unit of Teva Pharmaceutical Industries Ltd. (TEVA).

By Ganaxi Small Cap Movers:Biosante Pharmaceuticals (BPAX) announced after the market closed today that its lead product in development, Libigel, often incorrectly called Viagra for women, had failed based on an initial analysis of data from two pivotal phase 3 efficac

Sheff Station submits:Biosante’s potential breakthrough product, Libigel, is in Phase III clinical trials for the treatment of female sexual dysfunction. Libigel does not have a partner for the product, and currently there is no pharmaceutical product approved in the U.S.